Trial Outcomes & Findings for A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants (NCT NCT02180659)
NCT ID: NCT02180659
Last Updated: 2019-01-11
Results Overview
The primary efficacy endpoint is a responder analysis. A subject will be designated as a responder (meaning they have maintained stability) if they have no more than 2 of 6 months with any evidence of illicit opioid use. Evidence of illicit opioid use is defined as a positive opioid urine toxicology result or self-reported illicit opioid use.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-01-11
Participant Flow
First patient enrolled: 26 June 2014. Last patient completed: 18 May 2015 A total of 21 Investigators participated in the study, across 21 sites in the United States.
211 patient were screened and of those,177 subjects were enrolled and randomized into the study.
Participant milestones
| Measure |
Buprenorphine Implants + Placebo Tablets
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
89
|
|
Overall Study
COMPLETED
|
81
|
84
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Buprenorphine Implants + Placebo Tablets
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Subject incarcerated during conduct
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
AT REQUEST OF THE SPONSOR
|
0
|
1
|
Baseline Characteristics
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
Baseline characteristics by cohort
| Measure |
Buprenorphine Implants + Placebo Tablets
n=87 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 Years
n=5 Participants
|
39 Years
n=7 Participants
|
39 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
28 kg/m^2
n=5 Participants
|
27 kg/m^2
n=7 Participants
|
28 kg/m^2
n=5 Participants
|
|
Primary opioid of abuse
Prescription opioid pain reliever
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Primary opioid of abuse
Heroin
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Primary opioid of abuse
Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Primary opioid of abuse
Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Time since first opioid abuse
|
11.2 Years
n=5 Participants
|
11.5 Years
n=7 Participants
|
11.3 Years
n=5 Participants
|
|
Time from first diagnosis of opioid dependence
|
6.2 years
n=5 Participants
|
6.2 years
n=7 Participants
|
6.2 years
n=5 Participants
|
|
Buprenorphine Treatment (years)
|
3.5 years
n=5 Participants
|
3.4 years
n=7 Participants
|
3.5 years
n=5 Participants
|
|
Highest Dose of Buprenorphine Treatment Ever Taken (mg/day)
|
14 mg/day
n=5 Participants
|
14 mg/day
n=7 Participants
|
14 mg/day
n=5 Participants
|
|
Dose of BPN treatment prior to randomization.
2 mg/d
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Dose of BPN treatment prior to randomization.
4 mg/d
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Dose of BPN treatment prior to randomization.
6 mg/d
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Dose of BPN treatment prior to randomization.
8 mg/d
|
61 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The analyses included 173 subjects in the ITT population who received treatment and post-baseline evaluations.
The primary efficacy endpoint is a responder analysis. A subject will be designated as a responder (meaning they have maintained stability) if they have no more than 2 of 6 months with any evidence of illicit opioid use. Evidence of illicit opioid use is defined as a positive opioid urine toxicology result or self-reported illicit opioid use.
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use.
Responder
|
81 Participants
|
78 Participants
|
|
The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use.
Non-Responder
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
The secondary outcome is the percent of subjects with no urine illicit opioid use by month.
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 1 · Yes
|
80 Participants
|
84 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 1 · No
|
4 Participants
|
5 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 2 · Yes
|
80 Participants
|
79 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 2 · No
|
4 Participants
|
10 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 3 · Yes
|
83 Participants
|
78 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 3 · No
|
1 Participants
|
11 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 4 · Yes
|
80 Participants
|
80 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 4 · No
|
4 Participants
|
9 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 5 · Yes
|
81 Participants
|
79 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 5 · No
|
3 Participants
|
10 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 6 · Yes
|
76 Participants
|
76 Participants
|
|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Month 6 · No
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Secondary efficacy endpoint measures number of participants with evidence of urine illicit opioid use by month.
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 1 · Yes
|
4 Participants
|
5 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 1 · No
|
80 Participants
|
84 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 2 · Yes
|
7 Participants
|
12 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 2 · No
|
77 Participants
|
77 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 3 · Yes
|
7 Participants
|
21 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 3 · No
|
77 Participants
|
68 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 4 · Yes
|
8 Participants
|
22 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 4 · No
|
76 Participants
|
67 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 5 · Yes
|
8 Participants
|
22 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 5 · No
|
76 Participants
|
67 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 6 · Yes
|
12 Participants
|
25 Participants
|
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Month 6 · No
|
72 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Subjects in the ITT population with no self-reported use of any illicit drugs (opioid or non-opioid) by month of evaluation
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 20 · Yes
|
70 Participants
|
70 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 20 · No
|
11 Participants
|
16 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 4 · Yes
|
72 Participants
|
75 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 4 · No
|
12 Participants
|
14 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 8 · Yes
|
70 Participants
|
75 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 8 · No
|
13 Participants
|
14 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 12 · Yes
|
75 Participants
|
71 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 12 · No
|
8 Participants
|
17 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Weeek 16 · Yes
|
68 Participants
|
74 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Weeek 16 · No
|
13 Participants
|
14 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 24/EOT · Yes
|
68 Participants
|
68 Participants
|
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Week 24/EOT · No
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
The secondary outcome of measures of craving: desire to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no desire, and 100 mm is strongest possible desire.
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Day 1 (Baseline)
|
5.4 units on a scale
Standard Deviation 13.98
|
6.8 units on a scale
Standard Deviation 16.02
|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Week 4(Change from BL)
|
1.1 units on a scale
Standard Deviation 17.69
|
-1.5 units on a scale
Standard Deviation 13.93
|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Week 8(Change from BL)
|
-1.8 units on a scale
Standard Deviation 10.63
|
-2.2 units on a scale
Standard Deviation 16.38
|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Week 12(Change from BL)
|
-2.0 units on a scale
Standard Deviation 9.37
|
-2.2 units on a scale
Standard Deviation 16.38
|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Week 16(Change from BL)
|
-2.2 units on a scale
Standard Deviation 11.88
|
-2.3 units on a scale
Standard Deviation 17.36
|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Week 20(Change from BL)
|
-2.3 units on a scale
Standard Deviation 10.94
|
-3.8 units on a scale
Standard Deviation 16.17
|
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Week 24(Change from BL)
|
-2.3 units on a scale
Standard Deviation 11.15
|
-2.8 units on a scale
Standard Deviation 19.57
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
The secondary outcome measures the change in baseline in the Clinical opiate withdrawal scale (COWS), which is a scale consisting of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale with higher scores associated with greater withdrawal symptoms. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: 0-4=none/normal, 5-12=mild, 13-24=moderate, 25-36=moderately severe, more than 36=severe withdrawal.
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Week 16(Change from BL)
|
-2.4 units on a scale
Standard Deviation 15.36
|
-2.3 units on a scale
Standard Deviation 15.39
|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Week 20(Change from BL)
|
-2.8 units on a scale
Standard Deviation 12.03
|
-3.4 units on a scale
Standard Deviation 13.79
|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Day 1 (Baseline)
|
5.4 units on a scale
Standard Deviation 15.18
|
6.0 units on a scale
Standard Deviation 13.02
|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Week 4(Change from BL)
|
-0.8 units on a scale
Standard Deviation 12.70
|
-1.2 units on a scale
Standard Deviation 16.91
|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Week 8(Change from BL)
|
-2.0 units on a scale
Standard Deviation 11.45
|
-1.9 units on a scale
Standard Deviation 16.38
|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Week 12(Change from BL)
|
-2.3 units on a scale
Standard Deviation 11.12
|
-2.4 units on a scale
Standard Deviation 14.72
|
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Week 24(Change from BL)
|
-2.7 units on a scale
Standard Deviation 12.58
|
-1.9 units on a scale
Standard Deviation 18.97
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
The secondary outcome measures the change in baseline in the subjective opioid withdrawal scale (SOWS), which is a scale which is a subject self-assessment of withdrawal symptoms. The scale consists of 16 questions that rate the intensity of withdrawal from 0 (not at all) to 4 (extremely) with a cumulative score ranging from 0-64 (0 =not at all, 64=extremely)
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Day 1 (Baseline)
|
2.7 units on a scale
Standard Deviation 3.85
|
2.2 units on a scale
Standard Deviation 3.15
|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Week 4 (Change from BL)
|
0.3 units on a scale
Standard Deviation 55.56
|
0.3 units on a scale
Standard Deviation 5.51
|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Week 8(Change from BL)
|
-1.1 units on a scale
Standard Deviation 3.39
|
0.4 units on a scale
Standard Deviation 5.63
|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Week 12(Change from BL)
|
-0.4 units on a scale
Standard Deviation 5.53
|
-0.1 units on a scale
Standard Deviation 4.15
|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Week 16(Change from BL)
|
-0.2 units on a scale
Standard Deviation 5.23
|
-0.4 units on a scale
Standard Deviation 4.25
|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Week 20(Change from BL)
|
-0.9 units on a scale
Standard Deviation 4.47
|
-0.1 units on a scale
Standard Deviation 4.47
|
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Week 24(Change from BL)
|
0.1 units on a scale
Standard Deviation 5.26
|
0.1 units on a scale
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
The secondary outcome of measures of craving: Need to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no need, and 100 mm is strongest possible need.
Outcome measures
| Measure |
Buprenorphine Implants + Placebo Tablets
n=84 Participants
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 Participants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Day 1 (Baseline)
|
5.4 units on a scale
Standard Deviation 15.18
|
6.0 units on a scale
Standard Deviation 13.02
|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Week 4(Change from BL)
|
-0.8 units on a scale
Standard Deviation 12.70
|
-1.2 units on a scale
Standard Deviation 16.91
|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Week 8(Change from BL)
|
-2.0 units on a scale
Standard Deviation 11.45
|
-1.9 units on a scale
Standard Deviation 16.93
|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Week 12(Change from BL)
|
-2.3 units on a scale
Standard Deviation 11.12
|
-2.4 units on a scale
Standard Deviation 14.72
|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Week 16(Change from BL)
|
-2.4 units on a scale
Standard Deviation 15.36
|
-2.3 units on a scale
Standard Deviation 15.39
|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Week 20(Change from BL)
|
-2.8 units on a scale
Standard Deviation 12.03
|
-3.4 units on a scale
Standard Deviation 13.79
|
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Week 24(Change from BL)
|
-2.7 units on a scale
Standard Deviation 12.58
|
-1.9 units on a scale
Standard Deviation 18.97
|
Adverse Events
Buprenorphine Implants + Placebo Tablets
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Buprenorphine Tablets + Placebo Implants
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine Implants + Placebo Tablets
n=87 participants at risk
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 participants at risk
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Nervous system disorders
Convulsion
|
1.1%
1/87 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
0.00%
0/89 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Psychiatric disorders
Bipolar I Disorder
|
1.1%
1/87 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
0.00%
0/89 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
Other adverse events
| Measure |
Buprenorphine Implants + Placebo Tablets
n=87 participants at risk
Four 80 mg Probuphine implants + daily SL placebo tablets
Buprenorphine implant
sublingual placebo tablets
|
Buprenorphine Tablets + Placebo Implants
n=89 participants at risk
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
sublingual buprenorphine tablets
placebo implants
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
1.1%
1/87 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
0.00%
0/89 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion - Spontaneous
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Pregnancy, puerperium and perinatal conditions
Pediatric exposure to treatment
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/87 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
1.1%
1/89 • Number of events 1 • All AEs were documented and followed from the time the subject signed the ICF until 14 days after the EOT Visit (i.e., implant removal and discontinuation of SL BPN/placebo treatment) which was approximately 28 weeks. Serious adverse events and AEs designated as possibly related to study drug were followed until resolution or stabilization.
For the purpose of this report, AEs considered by the investigator to be possibly, probably, or definitely related to study drug are classified as study drug-related events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place